1. Field of the Invention
The present invention relates to a curving tip catheter that is inserted into and through the lumen of a blood vessel in a network of branching blood vessels of a body and which is adapted to be manipulated therethrough to a selected blood vessel branch within the network of branching blood vessels and which is further adapted to deliver or withdraw a fluid material to or from the selected vessel branch within the network of blood vessels.
The catheter of the present invention includes an elongate tubular body and a flexible tubular tip portion at the distal end of the tubular body. The catheter further includes a control mechanism located at the proximal end of the catheter which is coupled to the flexible tip portion of the tubular body. The control mechanism is adapted to bend or flex the flexible tip portion relative to the plane of the tubular body of the catheter in order that the flexible tip portion can guide the catheter to and through a selected vessel branch of a branching network of blood vessels of the body.
2. Description of the Prior Art
Heretofore, various catheters have been proposed which include bending or flexing tip members or other mechanisms attached thereto for guiding a catheter through branching vessels of a body. Examples of such previously proposed catheters are disclosed in the following U.S. patents and in the following Japanese patent publication:
______________________________________ U.S. PAT. NO. PATENTEE ______________________________________ 1,913,229 Bordier 3,416,531 Edwards 3,452,740 Muller 3,452,742 Muller 3,470,876 Barchilon 3,500,820 Almen 3,521,620 Cook 3,547,103 Cook 3,552,384 Pierie et al 3,605,725 Bentov 3,773,034 Burns et al 4,033,331 Guss et al 4,245,624 Komiya ______________________________________ Senzo Japanese Patent Publication No. 4327695
The Bordier U.S. Pat. No. 1,913,229 discloses an aspirating instrument adapted to be used in connection with aspirating devices which are used in medical and surgical practices. The aspirating instrument includes a body having two passageways formed therethrough and a flexible rod located within one of the passageways. The flexible rod carries an index flag which is adapted to indicate the position of the tip of the flexible rod when it is inserted into a cavity which is to be emptied of a liquid. The body of the instrument is first introduced into the cavity with the tip of the flexible rod extending beyond the distal end of the body and serving as a guide into the cavity to be evacuated.
The Edwards U.S. Pat. No. 3,416,531 discloses a catheter tube reinforced with braided wire and which includes a longitudinal passageway therethrough and which is adapted to be connected to a manipulatable handle. The manipulatable handle includes a flexible guide tube which is insertable into the catheter tube and includes a pull wire which is coupled to and controlled by the manipulatable handle and which can be inserted into the longitudinal passageway of the catheter tube. A bending element is located at the distal end of the pull wire and is insertable into the longitudinal passageway of the catheter tube. When the manipulatable handle to which the catheter tube is attached is rotated, the rotation of the handle causes the catheter tube, the guide tube, the pull wire and the bending element to rotate accordingly. The rotation of the handle further causes the frictional engagement of the bending element with the inside of the catheter tube so that the end or tip of the catheter tube bends when the wire is pulled by the manipulatable handle in order to guide the tip of the catheter into a branching artery.
The Muller U.S. Pat. No. 3,452,740 discloses a spring guide manipulator having a handle for attachment to and manipulation of a spring guide which is used to guide a catheter to specific locations within the circulatory system. The spring guide is formed from a continuous wire coil and includes a tensioning wire which extends therethrough. The distal end of the spring guide is closed by a catheter plug and the proximal end of the spring guide is connected to a front chuck in the manipulatable handle. The distal end of the wire is connected to the plug, and the proximal end of the wire is connected to a back chuck which is located behind the front chuck. When the manipulatable handle is connected to the proximal end of the spring guide and tension is applied to the tensioning wire by moving the back chuck axially away from the front chuck, the wire is axially displaced in order to flex the distal end of the spring guide.
The Muller U.S. Pat. No. 3,452,742 discloses a controllable vascular curvable spring guide comprising a wire coil and a core wire within the wire coil wherein the distal end of the core wire is permanently secured to the distal end of the wire coil by a cap. The arcuate portions of the individual coils of the spring guide along the inner radius of the spring guide have a decreased diameter relative to the increased diameter of their arcuate portions along the outer radius of the spring guide so that when a pulling force is applied to the wire toward the proximal end of the core wire, the distal tip of the spring guide will curve or bend toward the inner radius of the spring guide.
The Barchilon U.S. Pat. No. 3,470,876 discloses a dirigible catheter which includes an outer cylindrical wall member which is continuous along the length of the catheter and an inner catheter tube situated within the outer cylindrical wall member. An end piece having a flange is mounted around the distal end of the inner catheter tube. The flange receives four guiding or tensioning cords which are fastened to the flange and which extend through tube-like members within the catheter body. Accordingly, selective tensioning of one of the four tensioning cords will direct the distal end of the catheter in any direction throughout 360.degree. with respect to a plane perpendicular to the axis thereof. The catheter is further adapted to be mounted to a manipulatable device which contains a mechanism for selectively operating each of the tensioning cords.
The Almen U.S. Pat. No. 3,500,820 discloses a medical probe for injecting contrast medium into the body and which includes an outer hose, a flexible tube inserted within the hose which is slidably movable therein, and a bending element inserted in the tube and which is also slidably movable therein. The bending element consists of two relatively thin narrow wires having a rectangular cross-section and which have their distal ends soldered together and which extend through the distal end of the flexible inner tube. The proximal ends of the wires are connected to the handle and are movable back and forth in relation to each other and to the flexible tube so that when the wires are lengthened or shortened in relation to each other the distal end of the catheter is curved by the axial displacement of the wires of the bending element.
The Cook U.S. Pat. No. 3,521,620 discloses a vascular coil spring guide with a bendable tip which includes a coil spring and a wire extending within the coil spring which has its distal end attached to a tip member located at the distal end of the coil spring. The coil spring guide further includes a flat wire secured to the tip member of the coil spring and which occupies a small portion of the distal end of the coil spring. The flat wire is positioned adjacent or in engagement with the inside surface of the coil spring on one side of the coil spring and opposite the wire. The wire moves freely within the coil spring and its proximal end is connected to a controlling and holding tool located at the proximal end of the coil spring. When the wire is pulled or thereby manipulated by the controlling and holding tool, the distal end of the coil spring will bend in a direction opposite the side of the coil spring to which the flat wire is secured as a result of the rigidity provided by the flat wire to the side of the coil spring to which the flat wire is attached.
The Cook U.S. Pat. No. 3,547,103 discloses a coil spring guide having a mandrel therein extending from the proximal end of the spring guide toward and into the distal end of the spring guide. A wire also extends through the coil spring guide and extends beyond the distal end of the mandrel and is attached to a tip member located at the distal end of the spring guide. The coil spring and the wire are curved at the distal end of the spring guide so that the coil spring defines a J-shape so that when the proximal end of the spring guide is held with one hand and pulled with another hand, the wire is also pulled with the result that the distal end of the spring guide is straightened.
The Pierie et al U.S. Pat. No. 3,552,384 discloses a controllable tip guide body and catheter wherein the guide body comprises a flexible plastic tube having a flexible pull wire extending therethrough and attached to the distal end of the guide body so that when the pull wire is manipulated or pulled, the distal end of the guide body will bend.
The Bentov U.S. Pat. No. 3,605,725 discloses a controlled motion device which comprises a catheter body having a frusto-conical metal insert located at and within its distal end into which are mounted three flexible control wires positioned 120.degree. apart. The control wires extend rearwardly through passageways in the catheter body to a control housing located at the proximal end of the catheter body. The control housing includes a Y-shaped tube which communicates with a central passageway through the catheter body so that a stiff guide wire can be inserted through one of the arms of the Y-shaped tube and into the central passageway in order to facilitate insertion of a catheter into a blood vessel. When the guide wire is positioned into the distal end of the catheter, it stiffens a predetermined portion of the distal end of the catheter within which the guide wire occupies and permits the remaining portion of the distal end of the catheter which is unoccupied by the guide wire to flex by manipulation of the control wires by the control housing.
The Burns et al U.S. Pat. No. 3,773,034 discloses a steerable catheter which includes an elongate flexible tubular member having one or more passageways therethrough and a steerable fluid control apparatus connected to the proximal end of the tubular member. Bending of the distal end of the tubular member is controlled by a fluid force which is introduced by the fluid control apparatus into and through the passageways.
The Guss et al U.S. Pat. No. 4,033,331 discloses a cardiac catheter formed with a main lumen and a wire lumen extending throughout the length of the catheter wherein the main lumen is open from its proximal end through an opening at the distal end of the catheter, while the wire lumen is open from the proximal end of the catheter and is closed at the distal end of the catheter. The catheter is flexible throughout its length and has a deformable, preformed distal end that is formed with a set curvature so that when a stiffening wire, which slidably resides within the wire lumen, is removed, the distal end of the catheter will resume its preformed or sharply formed curved tip.
The Komiya U.S. Pat. No. 4,245,624 discloses an endoscope with a flexible tip control and which includes a tube section having first and second channels or passageways therethrough, a cylindrical guide tube slidably inserted through the first channel, and a slidable wire inserted through the second channel. The distal end of the wire is fixed to the outer wall of the guide tube at the distal end of the guide tube, and the other end of the wire extends through the tube section to a control section which is connected to the proximal end of the tube section. When the guide tube and the wire are made to move forward by the control section so that both the guide tube and the wire are simultaneously pushed out of the distal end of the tube section, the wire is then pulled toward the control section so that the flexible distal end of the guide tube is thereby bent.
The Senzo Japanese Patent Publication No. 43-27695 discloses a catheter which includes a tubular core which comprises a coiled helical wire and a control wire extending therethrough having its distal end welded to the distal end of the coiled wire, and the proximal end of wire connected to a control knob for manipulating the wire. When the wire is pulled by manipulating the control knob, the coiled end portion of the coiled helical wire is caused to reduce its interwiring spacing at the pulled side of the coiled wire to which the control wire is attached, thereby causing the distal end of the tubular core to bend in an arcuate form.
As will be described in greater detail hereinafter, the curving tip catheter of the present invention differs from the various catheters previously proposed by providing a catheter comprising a reinforced elongate tubular body having two separate passageways and having a distal end tip portion which is not reinforced so that the tip portion is flexible relative the reinforced tubular body. A pull wire slidably extends through one of the elongate passageways. A distal end of the pull wire is connected to the flexible tip portion, and a proximal end of the pull wire is connected to a control mechanism mounted to the proximal end of the tubular body. The control mechanism is adapted to be manipulated to bend the flexibility portion relative to the tubular body in a rearward direction toward the control housing in order to permit the catheter to be guided by the flexible tip portion into a selected blood vessel branch in a network of branching blood vessels.